7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RMI TRANSILLUMINATOR, MODEL 292
FDA 510(k)
FDA Class 2
·Ophthalmic
ENSEAL PTC TISSUE SEATING SEALING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 20, 2014
VIRTUOSO DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code LWS·October 9, 2010
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2012
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022